Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

Subjects enrolled in this 12-wk, double blind, randomized, placebo-controlled, clinical trial are admitted to a residential facility in North Little Rock (RCA-NLR) and randomized by depressive symptom severity to receive one of the following: sertraline alone (200 mg/day), sertraline (200 mg/day) plus gabapentin (1200 mg/day), or placebo. Subjects are expected to participate in the Substance Abuse Day Treatment Program while residing on the RCA-NLR and being inducted onto the maintenance dose of study medication (weeks 1-2). When participants transfer to the Outpatient Treatment Research Unit (TRU) at the start of their third week, they will continue to receive study medications or placebo (weeks 3-12) and they will be expected to participate in weekly individual cognitive behavioral therapy. Supervised urines and vital signs will be obtained thrice weekly; self-reported adverse effects, mood and drug use self-reports will be obtained once weekly. At the end of 12 weeks, participants will be tapered off the study medication over a five-day period, discharged from the study, and referred to an appropriate treatment or treatment/research program in the community if they are interested.

Inclusion criteria

• 18-65 years old
• not currently enrolled in a treatment program
• subjects must have a history of cocaine use, with street cocaine use by history being a minimum of 1 gram during the preceding 3 months
• subjects must meet DSM-IV criteria for cocaine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID and SCID-SAC)
• subjects must have laboratory confirmation of recent cocaine use (positive urine for cocaine or benzoylecgonine) during the month prior to study entry
• subjects must score at least 15 on the Hamilton Depression Scale
• women of childbearing age must have a negative pregnancy test to enroll in this study and must agree to monthly pregnancy testing

Exclusion criteria

• current diagnosis of other drug or alcohol physical dependence (other than cocaine or tobacco)
• ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
• history of schizophrenia, or bipolar type I disorder
• present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
• medical contraindication to receiving study medications (e.g., for sertraline, use of monoamine oxidase inhibitor within last two weeks; significant history of seizures; significant history of head trauma or serious neurological disorders)
• current suicidality or psychosis
• Liver function tests (i.e., liver enzymes) greater than three times normal levels
• pregnancy